"There are no opium cults. Opium is profane and quantitative like money [...] Junk is the ideal product . . . the ultimate merchandise. No sales talk necessary. The client will crawl through a sewer and beg to buy. . . . The junk merchant does not sell his product to the consumer, he sells the consumer to his product. He does not improve and simplify his merchandise. He degrades and simplifies the client." William S. Burroughs, "Deposition: Testimony Concerning a Sickness," 1960.
"OxyContin" is the brand-name for an opioid painkiller manufactured by Purdue Pharma L.P., which is a 1991 subsidiary of the Purdue Frederick Company. Formed in 1952 to sell antiseptics and laxatives, and headquartered in Stamford, Connecticut, Purdue Frederick got into "pain management" business in 1984, when it launched "MSContin," a slow-release morphine-derivative.
Pain is nature's way of telling people ("patients") that something is wrong and/or that an injury requires (more) time to heal. And yet, especially in America, there is a deep aversion to feeling pain, which means the "pain management" business (the sale and consumption of analgesic pharmaceuticals) is immense. In America, the sales revenue of opioid analgesics is over $2 billion a year, and is projected to grow by $455 million a year for the next five years. The pharmaceutical business as a whole generates $154 billion of revenue every year in the USA Prescriptions for MS Contin had risen to almost 1 million by 1996 The pharmaceutical industry is one of the largest in the country, with U.S. sales of $154 billion in 2001, up $22.4 billion from 2000[134]. Worldwide, sales of opioid analgesics were $4.7 billion in 2000, and are .[136] OxyContin, sold internationally by Mundipharma International, captured 31.5 percent of this market in 2000 with sales of $1.48 billion. The next highest market share product was the Duragesic patch by Johnson & Johnson with sales of $925 million, constituting 19.7 percent of the market. Farther behind, Mundipharma Internationals product MS Contin was ranked third, with sales of $230 million, making up 4.1 percent of the market. The sales growth of OxyContin was simply stunning for a company that only passed sales of $100 million in 1987. Introduced in 1984, another opioid analgesic product, MS Contin slow-release morphine, had been Purdue Pharmas highest grossing product until 1996. Prescriptions for MS Contin had risen to almost 1 million by 1996, though after OxyContins introduction its sales declined to less than 800,00 prescriptions in 2000. It was OxyContins introduction and astronomical sales which made Purdue one of the fastest growing pharmaceutical companies in the world. Sales of OxyContin passed $1 billion by 2000, only 4 years after its introduction, and had reached 6.8 million prescriptions and $1.49 billion by 2001. According to court documents filed by Purdue in connection with a patent dispute, OxyContin accounted for 83 percent of the privately held companys revenue in 2001. Purdue began funding patient advocacy groups, including the American Pain Foundation, the National Foundation for the Treatment of Pain, and the American Chronic Pain Association. Purdue also underwrote dozens of scientific studies on the effectiveness of opioids in the treatment of pain. Through these groups Purdue was able to pressure states to adopt various pain management and opioid use guidelines. As attitudes began to shift Purdue expanded the market for MS Contin beyond cancer pain. In 1994 Purdue launched a public-education program called Partners Against Pain. It initially concentrated on cancer pain, and later expanded to include other forms of long-term pain. Through videos, patient pain journals and an elaborate Web site, Purdue promoted the ideas that pain was much more widespread than had previously been thought, that it was treatable, and that in many cases it could and should be treated with opioids. No specific products were advocated, and Purdues name was not mentioned in any of the material. By 1995 Purdue began shifting its marketing resources away from MS Contin (as its patent had expired) and towards OxyContin. Using a marketing strategy increasingly common in the industry, Purdue paid for the transportation and hotel costs for 2000 to 3000 doctors to attend weekend meetings in Florida, California, and Arizona to discuss pain management issues. Doctors were then recruited and paid fees to speak at some of the 7,000 pain management seminars that Purdue sponsored around the country. The aggressive treatment of pain with long-acting opioid formulations was advocated. In 1996 Purdue had assembled an initial sales force of 350 and planned to devote 70 percent of their primary sales calls to OxyContin immediately after its introduction, reducing that to 40 percent in 2000. The initial sales forecast was $350 million dollars[137] over the first five years of the products life, but by the end of 2000 sales totaled nearly $2 billion. Realizing that it had drastically underestimated demand, Purdue quickly expanded its sales force to 800, and increased its percentage of primary sales calls to 80 percent. Other elements of the Purdue plan included the use of a group of doctors known as the Speakers Bureau to give lectures about the benefits of OxyContin during hospital programs. Doctors were also mailed information about the drug with a reply card which they could send back requesting more information. Purdue would then use the reply card to encourage local hospitals to stock the product. The active ingredient in OxyContin is oxycodone hydrocloride, which is a synthetic opiate (an "opioid"). Pure opium contains sugars, proteins, fats, water, meconic acid, plant wax, latex, gums, ammonia, sulphuric and lactic acids, and numerous alkaloids, most notably morphine (10%-15%), codeine (1%-3%), noscapine (4%-8%), papaverine (1%-3%), and thebaine (1%-2%). Of these components, modern medicine uses morphine, codeine, and a number of derivatives of thebaine. It is thebaine from which the majority of todays opioids are made. Thebaine has no analgesic effect itself, but can be used to synthesize hydrocodone (Vicodin), dihydromorphenone (Dilaudid), oxycodone (Percocet), and a number of other more obscure opioids. Completely synthetic morphine analogues include classes of drugs called the diphenylpropylamines (e.g. methadone), the 4-phenylpiperidines (e.g. meperidine), the morphinans (e.g. levorphanol) and 6,7-benzomorphans (e.g. metazocine). All contain a piperidine ring or part of its ring structure. The entire pharmacologically active class of drugs inspired by the opium poppy are called opioids. This term includes compounds which occur naturally in the plant, such as codeine and morphine, semi-synthetics, which are compounds made from the combination of an opium product and another chemical, such as diacetylmorphine (made from morphine) and oxycodone (made from thebaine), and pure synthetics, compounds which are made with chemicals from other sources, such as methadone and fentanyl. The term opiate refers only to natural and semi-synthetic compounds. Although opiate and opioid are often used interchangeably, use of the term opiate is incorrect when referring to two very popular modern drugs, methadone, used in pain management and opioid maintenance therapy, and fentanyl, used in the Duragesic patch for long-term pain management. Oxycodone is a semi-synthetic opioid derived from the opium alkaloid thebaine. It is typically made into the salt form, oxycodone hydrochloride, a white, odorless crystalline powder that is highly soluble in water and slightly soluble in alcohol. Its chemically known as 4, 5a-epoxy-14-hydroxy-3-methoxy-17 methylmorphinan-6-one hydrochloride. Oxycodone was originally synthesized in a German laboratory in 1916. It has been used in Europe by injection and orally since 1917. Oral 5mg oxycodone formulations have been available in the U.S. since the 1950's, typically combined with a co-analgesic agent such as aspirin or acetaminophen, which is referred to as a combination analgesic product. Common brand names have been Percodan, an aspirin formulation, and Percocet, Tylox, and Roxicet, acetaminophen formulations. In large doses, aspirin and acetaminophen can be toxic to the liver, stomach and kidneys. Therefore, drugs containing aspirin or acetaminophen are limited in their usefulness because a patient can only take up to a set amount per day to avoid toxicity. immediate-release tablet formulations with common brand names Roxicodone, Percolone, and OxyIR. A liquid formulation named OxyFast also became available. According to the FDA, there are 59 oxycodone containing products currently available in the United States as of 2002. These single-entity oxycodone formulations removed the potential for aspirin or acetaminophen toxicity, but the problem of dosing frequency and pill numbers still remained because the effective duration of oxycodone is only 4 hours. oxycodone is the opioid agent in around 40 separate brand-name prescription medications besides OxyContin; and OxyContin accounts for only about 25 percent of the oxycodone consumed annually. As a result, the United States Drug Enforcement Administration (the "DEA," a part of the Department of Justice) classifies opioids as Schedule II narcotics ("high potential for abuse") and treats them as controlled substances.
An 80mg dosage form was approved January 6, 1997, and a 160mg dosage form was approved March 15, 2000, though the company later suspended shipment of the product on May 11, 2001. Purdues first public move to show their concern was the withdrawal of the 160mg tablet formulation on June 18, 2001, only a year after it had been introduced. As sales of this formulation were only 1 percent of total OxyContin sales, it had little effect on Purdues bottom line and allowed them to demonstrate their concern over the dangers of abuse. The unique traits of this product were that it was available in dosage strengths two, four, eight, and sixteen times greater that previous oxycodone formulations, and that the oxycodone was released slowly, providing a duration of effect between 9 and 12 hours. At the time, competing products on the market for time-release high dose opioid formulations were 8, 12, and 24 hour oral formulations of morphine, and a 72 hour formulation of the opioid fentanyl in a skin patch. The current retail price for OxyContin tablets is $1.38 for 10mg tablets, $2.48 for 20mg tablets, $4.30 for 40mg tablets, and $8.16 for 80mg tablets. OxyContin generally has a black market value of $1 per milligram, so tablets which cost between $1.30 and $7.60 retail typically sell for $10 to $80 each on the street. Of even greater interests to addicts and abusers is the possibility of nasal administration of the drug, which leads to an onset of peak effect in 25 minutes[24], compared to 60-90 minutes from oral administration (this includes if the tablet is chewed, which causes a greater peak but the same rate of onset). The outer coating of the OxyContin tablet is easily scraped off or wiped off with a wet paper towel, and with moderate force the wax-matrix core can be crushed into a fine power. This powder has active oxycodone concentrated at approximately 300mg/g, compared to the roughly 12 mg/g resulting from a crushed Percocet tablet, a 25 fold greater concentration. When a user attempts to snort a Percocet tablet, the mucous membrane becomes saturated with powder, causing sub-optimal absorption of the drug, while with OxyContin powder, the mucous membrane allows complete absorption. Coupled with oxycodones approximately 60 percent[25] nasal bioavailability, relatively high compared to other opioids, such as morphine at approximately 10 percent[26], the phenomenon of nasal abuse of OxyContin has become popular.OxyContin is one of the most potent opioids ever made. In December 1995, it was approved for release into what the lawyers call "the stream of commerce" by the United States Food and Drug Administration (FDA), which believed Purdue Pharma's assertion that OxyContin was worth the risk of addiction because it could deliver something that no other painkiller on the market could: truly long-lasting pain relief. The other painkillers, no matter how strong, only last 4 to 6 hours, which meant that people had to take several doses per day to be properly relieved of their pain, which in turn meant that they were more likely to become addicted. OxyContin was said to last a full 12 hours: it contained a layer of special gel, located between the pill's drug-coated exterior and its drug-filled center, that was designed to dissolve very slowly and thus produce a "time-release" effect. To make sure the FDA to give its approval, Purdue Pharma said that OxyContin would only be prescribed to cancer patients and others suffering from chronic severe pain, and that the dosage in the various tablets themselves would be limited to 10, 20 and 40 milligrams, respectively. (A single 40-milligram OxyContin has as much synthetic opium as eight Percocets.)
First sold in the USA in May 1996, OxyContin was an immediate and immense success. In its first year, the new drug was prescribed 3.5 million times and generated $600 million in sales. (To this day -- despite all that has happened since then -- OxyContin remains an immense success: in 2003, it was prescribed 6 million times and generated sales revenues in excess of $1 billion.) But OxyContin's spectacular success hasn't been "natural." It's been the result of a thorough, highly coordinated, on-going and very cynical campaign (a "criminal conspiracy," if you prefer).
The primary targets of this campaign were the doctors, who are the ones, the only ones, who can prescribe Schedule II narcotics to their patients. They might not prescribe OxyContin (or any other opioid) because of their superior knowledge of the realities of addiction, access to accurate and current information, and abiding commitment to the oath "Do no harm." The doctors would surely know and have their prescribing habits affected by the fact that the American Medical Association (AMA) has found that as many as 19 percent of the people who take opioids become addicted to them.
Purdue Pharma went after the doctors two different ways, both of which violate the spirit, if not the actual letter, of the AMA's ethical guidelines. First, the company invited the doctors to attend all-expense-paid "pain management seminars," at which the praises of the new drug were sung and the dangers of opioid addiction were played down. (Purdue claimed that less than 1 percent of OxyContin users became addicted to it.) In some instances, the leaders of these seminars were other doctors whom Purdue Pharma had hired as salespeople. Second, the company's "detailers" (salespeople hired on commission) kept in constant touch with the doctors via telephone. Doctors who didn't want to prescribe OxyContin were pressured, even bribed (with "promotional materials" such as beach hats, coffee cups, music CDs and free lunches), to change their minds. And doctors who were or had been prescribing OxyContin were monitored to see if they were still prescribing it.
The campaign also targeted the pharmacists, who are the ones, the only ones, who can sell Schedule II narcotics. Even when presented with a valid prescription for OxyContin (or any other opioid, for that matter), a pharmacist might refuse to stock and sell it on the grounds that the potential for abuse and/or liability -- physical addiction, criminal "diversion" of lawful prescriptions, forged prescriptions, robberies -- was just too high. And so the pharmacists were "monitored" by the detailers, who wanted to make sure that they were stocking OxyContin and stocking "sufficient" quantities of it. (In the later stages of the campaign, especially when Purdue hooked up with Chicago-based Abbott Laboratories, the detailers also went after anesthesiologists and "pain experts" at hospitals.)
Last, but certainly not least, the campaign targeted the people suffering from pain, who are the ones, the only ones, who swallow the pills and run the risk of addiction. To convince them of the drug's desirability and safety, Purdue Pharma produced such "direct marketing" vehicles as magazine advertisements, printed brochures, videotapes and Web sites, all of them keyed to the theme "Partners Against Pain." Pain-sufferers were told that they shouldn't worry about becoming addicted, because "addiction" was only happened to people who took drugs to "get high," and not to people who took medicine to relieve pain. They were told that, if their respective doctors didn't prescribe OxyContin, they should find one who did.
During the course of this campaign, OxyContin was marketed as safe and effective for all types of pain, and not just chronic or severe pain. And so the drug was prescribed to and consumed by all kinds of people who should never have been taking it: elderly women suffering from osteoarthritis; people who had a history of alcoholism or abuse of illegal drugs; even children suffering from (temporary) headaches.
lower back pain, cancer, severe burns, migraine headaches, arthritis, myocardial ischemia, renal colic, and gout.Coincident with OxyContin's spectacular success, there were clear indications that there was something fundamentally wrong with the drug: it didn't last 12 hours; it only lasted about 6 hours. The special gel was dissolving much faster than it was supposed to. But rather than admit and correct this defect, which rapidly drove its users deeper and deeper into drug addiction, Purdue attempted to profit from it. In 1996, the company came out with 5 mg tablets of "OxyIR," which was designed to produce "immediate release" (or IR) from pain -- and that pain might be the "underlying" pain from which the patient was original suffering, or the "secondary" pain caused from withdrawal symptoms, that is, from the patient's newly acquired drug addiction. In 1997, finding that this stop-gap medication was insufficient to meet the demand it had created, Purdue started producing OxyContin tablets that contained 80-milligrams of oxycodone. But, owing to the viciousness of the cycle of addiction, even this dosage wasn't high enough. In July 2000, the company started producing 160-milligram tablets and planned to produce tablets containing even more (as much as 240 milligrams!)
However the major newspapers had yet to pick up on the OxyContin story. Small local papers in Maine and Kentucky began running stories with increasing frequency, but during the next six months, there were only 3 back-page stories in national newspapers which mentioned OxyContin, usually in reference to drugstore robberies. Finally, on February 8, 2001[30], The New York Times picked up on an announcement made the previous day that state and federal authorities in Kentucky had arrested 201 accused drug dealers for distributing the prescription drug OxyContin in a series of coordinated raids dubbed Operation OxyFest. The local U.S. attorney Joseph Famularo was quoted as saying that at least 59 people had died from OxyContin overdoses in eastern Kentucky during the prior year. The New York Times ran the Associated Press feed on page 20, but the next day, February 9, ran their own story on the front page. The headline read, Cancer Painkillers Pose New Abuse Threat.[31] That night, the ABC television show 20/20 had an episode called Painkiller Epidemic based on the Kentucky drug raids. Following suit, The Washington Post ran, Virginia Police Fear Rise of New Drug,[32] on the front page of its metro section the next morning. The major national newspapers had in fact been beaten to the punch by Time Magazine, which had run a story titled, The Potent Perils of a Miracle Drug,[33] on January 8. The line, OxyContin is a leading treatment for chronic pain, but officials fear it may succeed crack cocaine on the street, was run below the title. U.S. News & World Report featured an article titled, The Poor Mans Heroin,[34] on February 3, based on the arrest of Dr. Lilly in Ohio from the previous March. After a two month pause, on April 9, Newsweeks cover read Painkillers, and inside had the story titled, How One Town Got Hooked,[35] about the rampant abuse of oxy, as it was popularly referred to, in the rural town of Hazard, Kentucky. Another story in the same issue was titled, Playing with Pain Killers.[36] The entire six month episode of OxyContin media attention was effectively and tastefully capped off by the New York Times Magazine on July 29th with its cover story, The Alchemy of OxyContin: From Pain Relief to Drug Addiction,[48] about a rural town in West Virginia named Man.The turning point came in Jan 2001 In early January, Time Magazine became the first major media outlet in America to report on the growing abuse of a synthetic opioid prescription painkiller named OxyContin. published a story about overdoses and deaths that were attributable to OxyContin. "Pain Pills Blamed for Rash of Deaths" the Associated Press proclaimed. "The 'poor man's heroin,'" U.S. News described the drug. "Prescription Painkiller Gains Status as Thrill Pill," claimed the Indianapolis Star, while the Cincinnati Enquirer called it the "'Heroin of the Midwest;' Traffickers' and Abusers' First Choice." But none could match the Port St. Lucie News, which called it the "New Crack" and touted its "Heroin-Like High" in the same headline. A Virginia man was convicted of murder last month for selling OxyContin to a friend who later died; a Florida doctor was charged in July with murder and drug trafficking after four of his patients died from overdoses. The Drug Enforcement Administration had already begun to investigate OxyContin diversion and abuse on a small scale in 1999 and 2000, but as the media coverage hit in 2001 and congressional hearing appeared imminent, the DEA drastically stepped up its rhetoric and its investigation of physicians. Before a congressional subcommittee in August 2001, the director of the DEA made it clear that OxyContin was the agencys number one priority, characterized as a societal threat unlike any which had been seen for decades. Within six months, the DEA requested a budget allocation of $25 million to combat OxyContin diversion and abuse on top of the $114 million it was already requesting for its Diversion Control department. The diversion of OxyContin was due to its high street price; approximately $1 per milligram, nearly 10 times the pharmacy price. Stories were frequently reported about corrupt doctors making thousands of dollars through liberal prescription practices. Legitimate patients were sometimes selling their medication to supplement their income, and people were importing the drug from Mexico and Canada. Originally only popular in certain rural areas, the drug seemed to spread to urban areas as the intense media coverage brought it to attention, and the DEA predicted that the plague was heading west.
The number of oxycodone-related emergency-room visits a more reliable figure than oxycodone-related overdoses supports Berkholzs analysis. Such visits have increased 72 percent, from 3060 in the first half of 1999 to 5261 in the equivalent period in 2000, according to the federal governments Drug Abuse Warning Network (DAWN). shipments of 160 mg pills stopped May 2001 By October of 2002 Purdues efforts began to pay off. On October 17, 2002 a federal judge in Kentucky refused to grant class-action certification in Gevedon v. Purdue Pharma. In November, Burton v. Purdue Pharma became the first OxyContin lawsuit to be dismissed, brought by plaintiffs who claimed Purdue had failed to warn patients of the dangers of the medication. On December 19, 2002 in the California Superior Court for Los Angeles County, Judge Malcolm Mackey made a judgment in favor of Purdue on an unfair trade practices case brought by a California resident. The judge dismissed all the plaintiffs claims with prejudice, and ruled that California state court should not be deciding on an issue that is the subject of federal regulation. The most recent case to be decided was on March 19, 2003 in Kentucky federal court, where a judge dismissed the pending personal injury suit Couch v Purdue Pharma. This was the twenty-second case against Purdue to be dismissed in the past year.